Nutrition-support-team Based Intervention in Patients With Advanced Gastrointestinal Cancer (NSTBIPAGC)

August 19, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

Effect of Nutrition-support-team Based Intervention on Nutritional Status, Chemotherapy Tolerance and Prognosis in Patients With Advanced Gastrointestinal Cancer

The research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. All patients receive the nutritional risk assessment by the nutritional support team first, and patients with nutritional risk or malnutrition are randomly assigned to the study group and the control group. The study group receive nutritional intervention from the nutritional support team during the period of chemotherapy, while the control group receive routine nutritional support from their clinicians. In the control group, nurses execute the doctors' advice on nutrition, and the nutrition support team does not actively communicate with doctors about the nutritional risk of patients or interfere with it. The baseline characteristics, chemotherapy efficacy, adverse events and prognosis are collected in both groups. At last, data are analyzed to clarify the nutritional status and related factors of patients with advanced gastrointestinal cancer in our hospital, and most important to explore the effect of nutrition-support-team intervention on nutritional status, chemotherapy tolerance and prognosis of patients with advanced gastrointestinal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Baseline data include age, gender, pain, sleep condition, family care, tumor type, tumor stage, combined disease, chemotherapy regimen and concomitant medication.

Nutritional risk assessments are performed by the nutrition support team just after enrollment, every two cycles of chemotherapy and at the end of the study. The adverse events of chemotherapy are collected and recorded at the end of each cycle. CT or MRI is performed to evaluate efficacy of chemotherapy every two treatment cycles. Patient after one treatment cycle can receive CT or MRI in advance if the clinical condition is worsening.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • advanced (recurrent or metastatic) gastrointestinal malignancies confirmed by pathology, plan to be treated with chemotherapy
  • the expected life period is more than 3 months
  • did not receive chemotherapy, radiotherapy, molecular targeted therapy or surgery in the last 4 weeks
  • has been recovered from the acute toxicity of previous treatment (if patient received surgery, the wound must have completely healed)
  • at least one measurable lesion according to RECIST 1.1 edition (the measurable lesion has not received radiotherapy)
  • normal function of main organs:Blood routine examination needs to be met: Hb≥90g/L (without blood transfusions within 14 days); ANC≥1.5×109/L; PLT≥80×109/LBiochemical examination should conform to the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN (ALT and AST≤5×ULN, in case of liver metastasis); Serum creatinine ≤1×ULN, creatinine clearance rate >50ml/min (Cockcroft-Gault formula)
  • volunteer to participate in the study, sign the informed consent, and cooperate with good compliance

Exclusion Criteria:

  • pregnancy or lactation
  • having a long-term unhealed wound, traumatic or pathological fracture
  • urinary protein > 2+ or 24 hour urinary protein >1.0g
  • suffering from mental illness
  • with hypertension and fail to get good control through antihypertensive medication (systolic pressure >140mmHg and/or diastolic pressure >90mmHg)
  • serious diabetes, heart disease (including but not limited to myocardial ischemia, myocardial infarction, cardiac insufficiency, congestive heart failure), thrombotic diseases (including but not limited to cerebral hemorrhage, deep venous thrombosis and pulmonary embolism)
  • long-term use of steroid for other medical reasons
  • with diseases that may increasing the underlying research risk judged by researchers
  • having a bleeding tendency or a great worry of gastrointestinal bleeding
  • with infection requiring antibiotic treatment
  • history of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders
  • patients with Hepatitis B(except inactive carrier) or Hepatitis C
  • took part in other clinical studies or is involved in other research projects at present

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NST group
Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy
Other: NST group
Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education
NO_INTERVENTION: routine group
clinicians decide whether to give and how to give the dietary supplement and other nutritional support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutritional status
Time Frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments
From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chemo-related adverse events
Time Frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
amount of chemo-related adverse events
From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
total chemotherapy cycles
Time Frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
amount of total cycles of chemotherapy
From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
progression-free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
the survival time of patient without progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
adverse events
Time Frame: From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months
Amount of adverse events related to nutritional intervention
From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Lingxiao Zhang, doctor, First Affiliated Hospital of Xian Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 20, 2018

Primary Completion (ANTICIPATED)

August 20, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (ACTUAL)

August 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 19, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2017-027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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